Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro cytogenicity / chromosome aberration study in mammalian cells

Remarks:

Type of genotoxicity: chromosome aberration

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Short Summary only

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)

Deviations:

no

GLP compliance:

not specified

Type of assay:

in vitro mammalian chromosome aberration test

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

EC Number:

276-857-1

EC Name:

Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)

Cas Number:

72812-34-1

Molecular formula:

C32H18CrN6O8.C11H25NO.H

IUPAC Name:

Chromate(1-), [1-[2-[2-(hydroxy-kO)-4-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO][1-[2-[2-(hydroxy-kO)-5-nitrophenyl]diazenyl-kN1]-2-naphthalenolato(2-)-kO]-, hydrogen, compd. with 3-[(2-ethylhexyl)oxy]-1-propanamine (1:1:1)

Method

Species / strain

Species / strain / cell type:

primary culture, other: human lymphocytes

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

up to 333 µg/ml

Vehicle / solvent:

no data

Details on test system and experimental conditions:

In the absence of S9-mix the test item was tested up to 178 and 133 µg/ml for a 24 hand 48 h fixation period respectively in the first experiment and up to 100 µg/ml in the second experiment. In the presence of S9-mix the test item was tested up to 333 µg/ml for a 24 h and 48 h fixation period in both experiments. In the independent repeat the 48 h fixation period was not performed.

Results and discussion

Test results

Species / strain:

primary culture, other: human lymphocytes

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
other: not clastogenic in human lymphocytes

The test substance is not clastogenic in
human lymphocytes.

Executive summary:

This report describes the effect of the test item on the induction of chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (Aroclor-1254 induced rat liver·S9-mix).

In the absence of S9-mix the test item was tested up to 178 and 133 µg/ml .for a 24 hand 48 h fixation period respectively in the first experiment and up to 100 µg/ml in the second experiment. In the presence of S9-mix the test item was tested up to 333 µg/ml for a 24 h and 48 h fixation period in both experiments. In the independent repeat the 48 h fixation period was not performed. None of the tested concentrations induced a statistically and biologically significant increase in the number of cells with chromosome aberrations, neither in the absence nor in the presence of S9-mix.

Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were optimal and that the metabolic activation system (S9-mix) functioned properly. It is concluded that the test substance is not clastogenic in human lymphocytes under the experimental conditions described in this report.